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All patients in this arm will receive OTL38 for injection and undergo intraoperative imaging.

Folate analog ligand conjugated with an indole cyanine-like green dye as a solution in vials containing 3 mL at 2 mg/mL

OTL38 for Injection

Near infrared camera imaging system

Endoscopic or Thoracic Surgery

Sunil Singhal, MD

This is a phase 2, multi-center, single dose, open-label, exploratory study in suspected lung cancer patients scheduled to undergo endoscopic or thoracic surgery per CT/positron emission tomography imaging based on standard of care. This study aims to assess the efficacy of OTL38 and Near Infrared Imaging (NIR) at identifying pulmonary nodules within the operating theater, and to assess the safety and tolerability of single intravenous doses of OTL38.

This is a phase 2, multi-center, single dose, open-label, exploratory study in suspected lung cancer patients scheduled to undergo endoscopic or thoracic surgery per CT/positron emission tomography (PET) imaging based on standard of care.

Two to three hours prior to surgery, patients will be infused with OTL38. After the patient is intubated and surgical site incised, the surgeon will locate and document all nodules identifiable by white light, manual palpation, and Near-Infrared Imaging (NIR). This will be documented and recorded. Surgery will be completed per surgeon's standard of care, afterwards the area will be reviewed under standard and infrared light. All samples will be sent for pathology and immunohistochemistry (IHC) evaluation.

OTL38 Injection for Intraoperative Imaging of Folate Receptor Positive Lung Nodules

A Phase 2, Single Dose, Open-Label, Exploratory Study to Investigate the Safety and Efficacy of OTL38 Injection for Intraoperative Imaging of Folate Receptor Positive Lung Nodules

Sensitivity or True Positive Rate (TPR) for OTL38 in combination with fluorescent light, defined as the proportion of fluorescent light positive tissue samples (nodule, synchronous lesion, and margin but excluding lymph nodes) that are histologically confirmed to be FR+ and lung cancer by central pathology relative to the total number of tissue samples confirmed to be FR+ and lung cancer by central pathology.

Sensitivity = (True Positive)/(True Positive +False Negative)

False positive rate (FPR) for OTL38 in combination with fluorescent light, for the purpose of this protocol, will be calculated as 1 - the Positive Predictive Value (PPV) and is defined as the proportion of fluorescent light positive tissue samples removed (nodule, synchronous lesion, and margin but excluding lymph nodes) that are histologically confirmed to be non-cancerous, or if cancerous, not FR+ and lung cancer, by central pathology relative to the total number of tissue samples removed with fluorescent light imaging. False Positive Rate = (False Positives) / (True Positives + False Positives)

Proportion of patients with at least 1 Clinically Significant Event (CSE as a result of utilizing OLT-38 and Near Infrared Imaging

Number of patients where at least one positive margin (fluorescent cancerous cells within 5 mm of the staple line) is identified with only OTL-38 and NIR

Number of patients where at least one synchronous lesions is identified only with OTL-38 and NIR

Number of pulmonary nodules identified with OTL-38 and Near Infrared Imaging (NIR) that could not otherwise be identified by white light and palpation.

Medelis Inc.

On Target Laboratories, LLC

All patients in this arm will receive OTL38 for injection and undergo intraoperative imaging.

OTL38 for Injection: Folate analog ligand conjugated with an indole cyanine-like green dye as a solution in vials containing 3 mL at 2 mg/mL

Near infrared camera imaging system: Near infrared camera imaging system

Endoscopic or Thoracic Surgery: Endoscopic or Thoracic Surgery

Patients Receiving OTL38

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Netherlands

United States

Region of Enrollment

Tim Biro

The FAS for the analysis of the two co-primary endpoints, sensitivity and FPR, included patients exposed to OTL38 who:

* Were evaluated under both normal light and fluorescent light imaging, and
* Had central pathology and histology confirmation (positive for FR+ Lung Cancer) for at least one tissue sample detected under normal light or fluorescent light imaging

Sensitivity or True Positive Rate (TPR)

False Positive Rate (FPR)

Proportion of Patients With at Least 1 Clinically Significant Event (CSE)

Positive Margin Identification

Synchronous Lesion Identification

Pulmonary Nodule Identification

Overall Study

All patients in this arm will receive OTL38 for injection but will not receive intraoperative imaging.

This is a phase 3, multi-center, single dose, open-label, exploratory study in suspected lung cancer patients scheduled to undergo endoscopic or thoracic surgery per CT/PET/MRI or other imaging based on standard of care. This study aims to assess the efficacy of OTL38 and Near Infrared Imaging (NIR) at identifying pulmonary nodules within the operating theater, and to assess the safety and tolerability of single intravenous doses of OTL38.

ELUCIDATE: Enabling Lung Cancer Identification Using Folate Receptor Targeting

A Phase 3, Randomized,Single Dose, Open-Label Study to Investigate the Safety and Efficacy of OTL38 Injection for Intraoperative Imaging of Folate Receptor Positive Lung Nodules

The primary efficacy endpoint is the proportion of patients who demonstrate at least one CSE as a result of utilizing OTL-38 and Near Infrared Imaging.

Proportion of FAS subjects with one or more primary NIR fluorescence positive lung nodules (cancerous or non-cancerous, excluding normal lung parenchyma) not detected under normal light and/or palpation

The proportion of FAS subjects with one or more NIR fluorescence positive cancerous synchronous lesions not detected under normal light and/or palpation

The proportion of FAS subjects with the identification of a cancerous positive margin that fluoresces within (less than or equal to) 10 mm of the surgical resection staple line

Sensitivity or True Positive Rate (TPR) for OTL38 used with fluorescent light in FAS subjects, defined as the proportion of fluorescent light positive primary nodules and synchronous lesions that are histologically confirmed to be cancer relative to the total number of primary nodules and synchronous lesions confirmed to be cancer.

False Positive Rate (FPR) for OTL38 used with fluorescent light in FAS subjects, defined as the proportion of fluorescent light positive primary nodules and synchronous lesions that are histologically confirmed not to be cancer relative to the total number of fluorescent light positive primary nodules and synchronous lesions

Clinipace Worldwide

All patients in this arm will receive OTL38 for injection and undergo intraoperative imaging.

OTL38 for Injection: Folate analog ligand conjugated with an indole cyanine-like green dye as a solution in vials containing 3 mL at 2 mg/mL

Near infrared camera imaging system: Near infrared camera imaging system

Near-Infrared Imaging Group

All patients in this arm will receive OTL38 for injection but will not receive intraoperative imaging.

OTL38 for Injection: Folate analog ligand conjugated with an indole cyanine-like green dye as a solution in vials containing 3 mL at 2 mg/mL

No Imaging Group

Total

Tommy Lee

The full analysis set will include subjects exposed to OTL38 and randomized to undergo NIR fluorescent imaging (OTL38+Imaging) who were evaluated under both normal light and NIR fluorescent light imaging

Full Analysis Set (FAS)

Full Analysis Set (FAS): The FAS for the primary analysis of the primary efficacy endpoint will include subjects exposed to OTL38 and randomized to undergo fluorescent imaging (OTL38+Imaging) who:

• Were evaluated under both normal light/palpation and NIR fluorescent light imaging

Clinically Significant Events (CSE)

Fully Analysis Set (FAS)

Localization of Primary Nodule

Identification of Cancerous Synchronous Lesions

Positive Resection Margins

Total number of Subjects with Evaluated Tissues

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
OTL38 Injection for Intraoperative Imaging of Folate Receptor Positive Lung Nodules	NCT02872701	Lung Neoplasms Lung Cancer	OTL38 for Injec... Near infrared c... Endoscopic or T...	18 Years - 85 Years	On Target Laboratories, LLC
ELUCIDATE: Enabling Lung Cancer Identification Using Folate Receptor Targeting	NCT04241315	Lung Neoplasms Lung Cancer	OTL38 for Injec... Near infrared c...	18 Years -	On Target Laboratories, LLC
OTL38 Injection for Intraoperative Imaging of Folate Receptor Positive Lung Nodules	NCT02872701	Lung Neoplasms Lung Cancer	OTL38 for Injec... Near infrared c... Endoscopic or T...	18 Years - 85 Years	On Target Laboratories, LLC
OTL38 Injection for Intraoperative Imaging of Folate Receptor Positive Lung Nodules	NCT02872701	Lung Neoplasms Lung Cancer	OTL38 for Injec... Near infrared c... Endoscopic or T...	18 Years - 85 Years	On Target Laboratories, LLC

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